How Should Drug and Natural Health Product Companies Report Safety Information?
Official title: Consultation: Draft guidance on preparing and submitting summary reports for marketed drugs and natural health products
Why This Matters
Take vitamins, supplements, or prescription medications? This consultation shapes how companies must report safety concerns to Health Canada. Better reporting means potential problems with drugs or natural health products get flagged faster. While this is mainly an industry consultation, the outcome affects how quickly safety issues reach regulators.
What Could Change
Drug and natural health product companies would face updated reporting requirements. The guidance consolidates existing rules into clearer, plain-language documents. Companies would also use a new form to notify Health Canada when significant new information emerges about a product's risks or benefits.
Key Issues
- Are the revised guidance documents clear and easy to follow?
- Does the new notification form capture the right information about product risks and benefits?
- How well do the updated submission processes work for industry?
How to Participate
- Review the draft guidance on preparing and submitting summary reports and the draft notification form.
- Send your comments by email to mhpdpolicy-politiquesdpsc@hc-sc.gc.ca with the subject line "Summary Reporting Guidance – Consultation Comments".
Submit Your Input
Questions Being Asked (2)
- What are your comments on the draft guidance document?
- What are your comments on the draft notification form for significant changes in product risks and benefits?
Key Documents
- Draft Guidance on Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products (opens in new tab)
- Draft Form: Notifying Health Canada of a Significant Change in Product Risks and Benefits (opens in new tab)
- Current Guidance: Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products (opens in new tab)